Tayside Clinical Trials Unit, University of Dundee, Dundee, UK
Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.
BMJ Open. 2019 Aug 8;9(8):e029516. doi: 10.1136/bmjopen-2019-029516.
Hepatitis C is a blood-borne virus (HCV) that can seriously damage the liver and is spread mainly through blood-to-blood contact with an infected person. Over 85% of individuals who have HCV in Scotland became infected following injecting drug use. Since people who inject drugs (PWID) are the main source of new infections, theoretical modelling has suggested that treatment of HCV infection in PWID may effectively reduce HCV prevalence and accomplish elimination. This protocol describes a clinical trial delivering HCV treatment within injecting equipment provision sites (IEPS) in Tayside, Scotland.
PWID attending IEPS are tested for HCV and, if they are chronically infected with HCV and eligible, invited to receive treatment within the IEPS. They are randomised to one of three treatment regimens; daily observed treatment, treatment dispensed every 2 weeks and treatment dispensed every 2 weeks together with an adherence psychological intervention (administered before treatment begins). The primary outcome is comparison of the rate of successful treatment (SVR) in each treatment group. Secondary analyses include assessment of adherence, reinfection rates, viral resistance to treatment and interaction of the treatment with illicit drugs.
The ADVANCE (A Direct obserVed therApy versus fortNightly CollEction) HCV trial was given favourable opinion by East of Scotland Research Ethics Committee (LR/17/ES/0089) prior to commencement.
European Clinical Trials Database (EudraCT) (2017-001039-38) and ClinicalTrials.gov (NCT03236506).
丙型肝炎是一种血源性病原体（HCV），可严重损害肝脏，主要通过与感染者的血液接触传播。苏格兰超过 85%的 HCV 感染者是在注射吸毒后感染的。由于注射吸毒者（PWID）是新感染的主要来源，理论模型表明，对 PWID 中的 HCV 感染进行治疗可能有效降低 HCV 流行率并实现消除。本方案描述了一项在苏格兰泰赛德的注射设备提供点（IEPS）内提供 HCV 治疗的临床试验。
在 IEPS 就诊的 PWID 接受 HCV 检测，如果他们慢性感染 HCV 且符合条件，将被邀请在 IEPS 内接受治疗。他们被随机分配到三种治疗方案之一：每日观察治疗、每两周一次的治疗和每两周一次的治疗加上治疗前的依从性心理干预（在治疗开始前进行）。主要结局是比较每个治疗组的成功治疗（SVR）率。次要分析包括评估依从性、再感染率、对治疗的病毒耐药性以及治疗与非法药物的相互作用。
在开始之前，苏格兰东部研究伦理委员会（LR/17/ES/0089）对 ADVANCE（直接观察治疗与每两周收集）HCV 试验给予了有利意见。
欧洲临床试验数据库（EudraCT）（2017-001039-38）和 ClinicalTrials.gov（NCT03236506）。
